A Study of Safety, Tolerability, Pharmacokinetic and Pharmacodynamics (PK/PD) in Patients With Hematologic Malignancies

Overview

Información sobre este estudio

The purpose of this study is to evaluate the safety and tolerability of APG-2575 as well as dose escalation and dose expansion stages.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

1. Age ≥18 years old.

2. Histologically confirmed diagnosis of either one of the B-cell hematologic
malignancies including multiple myeloma, chronic lymphocytic leukemia,
lymphoplasmacytic lymphoma, and non-Hodgkin's lymphoma such as mantle cell lymphoma,
diffuse large B cell lymphoma, Waldenstrom macroglobulinemia (WM) and acute myeloid
leukemia

3. Patient must have relapsed or refractory to, intolerant to, or are considered
ineligible for therapies known to provide clinical benefit. In addition,

a. AML Patients will be eligible if they have failed standard induction regimen, are
not considered candidate for further chemotherapy or stem cell transplantation or have
primary refractory AML.

4. Life expectancy ≥ 3 months.

5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -1 in dose
escalation ; 0-2 in dose expansion.

6. QTc interval ≤450ms in males, and ≤470ms in females.

7. Adequate bone marrow function independent of growth factor:

8. Absolute neutrophil count (ANC) ≥1.0 X 109/L.

9. Hemoglobin ≥ 8.0 g/dL.

10. Platelets count ≥ 30 X 109/L (entry platelet count must be independent of transfusion
within 7 days of first dose).

11. Adequate renal and liver function as indicated by:

Exclusion Criteria:

Patients who meet any of the following exclusion criteria are not to be enrolled in this
study:

1. Prior history of allogeneic cell transplant.

2. Subjects have been diagnosed with Burkitt's lymphoma, Burkitt-like lymphoma, or
lymphoblastic lymphoma/leukemia.

3. Received chemotherapy within 14 days (42 days for nitrosoureas or mitomycin C) prior
to entering the study.

4. Received biologic (< 28 days), small molecule targeted therapies (< 5 half-life) or
other anti-cancer therapy within 21 days of study entry.

5. Radiation within 14 days of study entry, thoracic radiation within 28 days of study
entry.

6. Has gastrointestinal conditions that could affect the absorption of APG-2575 in the
opinion of the Investigator.

7. Has known active central nervous system (CNS) involvement.

8. Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not
recover to ≤ Grade 1 except alopecia or neuropathy.

9. Concurrent treatment with an investigational agent, 14 days for small molecular agents
and/or 28 days for biologics treatment prior to the first dose of therapy.

10. Failure to recover adequately, as judged by the investigator, from prior surgical
procedures. Patients with active wound healing, patients who have had major surgery
within 28 days from study entry, and patients who have had minor surgery within 14
days of study entry.

11. Unstable angina, myocardial infarction, or a coronary revascularization procedure
within 180 days of study entry.

12. Active rheumatoid arthritis (RA), active inflammatory bowel disease, chronic
infections, or any other disease or condition associated with chronic inflammation.

13. Active infection requiring systemic antibiotic/ antifungal medication, known
clinically active hepatitis B or C infection, or on antiretroviral therapy for HIV
disease.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/31/22. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Sameer Parikh, M.B.B.S.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Sikander Ailawadhi, M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Jose Leis, M.D., Ph.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available

Información adicional de contacto

Formulario de contacto para ensayos sobre cáncer

Teléfono: 855-776-0015 (toll-free)

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